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3 . 2025

Endovascular versus hybrid interventions for steno-occlusive lesions of the iliofemoral segment (a pilot prospective randomized trial)

Abstract

Objective. The purpose of the study was to compare safety and efficacy of endovascular treatment (EVT) and hybrid repair (HR) using “Supera” stents in patients with combined lesions of the iliac arteries and common femoral artery.

Patients and methods. This pilot randomized study was registered on ClinicalTrials.gov (identifier: NCT03315884). The patients in the EVT group after recanalization and balloon angioplasty of the iliac arteries and common femoral artery underwent throughout stenting. The HR-group patients were subjected to recanalization and stenting of the iliac arteries in combination with endarterectomy from the common femoral artery and angioplasty with a xenopericardial patch. We compared short-term (30-day) and one-year results, including complications and patency rates.

Results. A total of 62 patients were randomized into two equal groups (31 EVT and 31 HR). The average length of the hospital stay in the EVT-group patients amounted to 3.9±1.2 days vs 7.9±2.7 days in the HR group, p=0.001. 30-day complication rates were 9.7% and 22.6% in the EVT and HR groups, respectively, p=0.17. Primary patency was 81% in the EVT group and 94% in the HR group, p=0.12. There were no statistically significant differences in secondary and primary assisted patency during 12 months, with no myocardial infarction, lethal outcomes, nor amputation.

Conclusion. The findings of this pilot randomized trial demonstrated safety and one-year efficacy of EVT in patients with tandem lesions of the iliac and common femoral arteries. The EVT-group patients showed a shorter length of hospital stay, a tendency toward a decrease in perioperative complications, and comparable to HR parameters of primary patency within 12 months.

Keywords: occlusions of iliac arteries; hybrid operations; TASCII type C, D lesions; stenting and endarterectomy from the common femoral artery

Funding. The study had no financial support.

Conflict of interest. The authors declare no conflict of interest.

Authors’ contribution. Research concept and design – Saaya Sh.B., Starodubtsev V.B., Karpenko A.A.; data collection and analysis – Saaya Sh.B., Khomushku D.V., Gostev A.A., Cheban A.V. Osipova O.S.; compilation of the article – Saaya Sh.B., Gostev A.A., Ignatenko P.V., Starodubtsev V.B.; verification of the article – Gostev A.A., Starodubtsev V.B., Karpenko A.A.; final approval of the version to be published – Saaya Sh.B., Khomushku D.V., Gostev A.A., Cheban A.V. Osipova O.S., Ignatenko P.V., Starodubtsev V.B., Karpenko A.A.

For citation: Saaya Sh.B., Khomushku D.V., Gostev A.A., Cheban A.V., Osipova O.S., Ignatenko P.V., Starodubtsev V.B., Karpenko A.A. Endovascular versus hybrid interventions for steno-occlusive lesions of the iliofemoral segment (a pilot prospective randomized trial). Angiology and Vascular Surgery. Journal named after Academician A.V. Pokrovsky. 2025; 31 (3): 102–10. DOI: https://doi.org/10.33029/1027-6661-2025-31-3-102-110

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CHIEF EDITOR
CHIEF EDITOR
Yuri V. Belov
Academician of the Russian Academy of Sciences Doctor of Medical Sciences, Professor, President of the Russian Society of Angiologists and Vascular Surgeons

 

In accordance with the decision of the Presidium of the Russian Society of Angiologists and Vascular Surgeons, the journal "Angiology and Vascular Surgery" will be named after Academician A.V. Pokrovsky starting from No. 2/2022.

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